ID

31110

Beschrijving

A Study of Enzastaurin and Erlotinib in Patients With Solid Tumors and Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00452413

Link

https://clinicaltrials.gov/show/NCT00452413

Trefwoorden

Versies (1)
  1. 20-07-18 20-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00452413

Engels

Eligibility Non-Small Cell Lung Cancer NCT00452413

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. phase 1: any incurable solid malignancy, with no more than 3 prior systemic treatment regimens.
Beschrijving

Solid Neoplasm incurable | Systemic therapy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0175969
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1265611
phase 2: histologic diagnosis of advanced nsclc, stage iiib with malignant pleural effusion or stage iv per american joint committee on cancer staging criteria for nsclc. patients must have failed 1 or 2 prior systemic treatment regimen(s).
Beschrijving

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Pleural Effusion, Malignant | Systemic therapy Quantity failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0080032
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0231175
2. performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) scale
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
3. prior chemotherapy must be completed at least 2 weeks prior to study enrollment, and the patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
Beschrijving

Prior Chemotherapy Completed | Toxicity Patient recovered | Exception Alopecia

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1115804
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
4. prior radiotherapy is allowed to < 25% of the bone marrow prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
Beschrijving

Prior radiation therapy Bone Marrow Percentage | Prior radiation therapy Completed | Toxicity Patient recovered | Exception Alopecia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C1115804
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0002170
5. non-measurable or measurable disease as defined by recist.
Beschrijving

Disease Non-Measurable | Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [2]
C1513041
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. are unable to swallow tablets.
Beschrijving

Lacking Able to swallow Tablets

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
2. unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
Beschrijving

Unable to discontinue Carbamazepine | Unable to discontinue Phenobarbital | Unable to discontinue Phenytoin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548265
UMLS CUI [1,2]
C0006949
UMLS CUI [2,1]
C1548265
UMLS CUI [2,2]
C0031412
UMLS CUI [3,1]
C1548265
UMLS CUI [3,2]
C0031507
3. have previously been treated with an epidermal growth factor receptor (egfr) inhibitor, including erlotinib.
Beschrijving

Epidermal growth factor receptor inhibitor | erlotinib

Datatype

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2]
C1135135
4. are receiving concurrent administration of any other antitumor therapy.
Beschrijving

Cancer treatment Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
5. have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
Beschrijving

Drugs, Non-Prescription

Datatype

boolean

Alias
UMLS CUI [1]
C0013231
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00452413

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Solid Neoplasm incurable | Systemic therapy Quantity
Item
1. phase 1: any incurable solid malignancy, with no more than 3 prior systemic treatment regimens.
boolean
C0280100 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Pleural Effusion, Malignant | Systemic therapy Quantity failed
Item
phase 2: histologic diagnosis of advanced nsclc, stage iiib with malignant pleural effusion or stage iv per american joint committee on cancer staging criteria for nsclc. patients must have failed 1 or 2 prior systemic treatment regimen(s).
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0080032 (UMLS CUI [2])
C1515119 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
ECOG performance status
Item
2. performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) scale
boolean
C1520224 (UMLS CUI [1])
Prior Chemotherapy Completed | Toxicity Patient recovered | Exception Alopecia
Item
3. prior chemotherapy must be completed at least 2 weeks prior to study enrollment, and the patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
boolean
C1514457 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
Prior radiation therapy Bone Marrow Percentage | Prior radiation therapy Completed | Toxicity Patient recovered | Exception Alopecia
Item
4. prior radiotherapy is allowed to < 25% of the bone marrow prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3,1])
C1115804 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0002170 (UMLS CUI [4,2])
Disease Non-Measurable | Measurable Disease
Item
5. non-measurable or measurable disease as defined by recist.
boolean
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients who
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Lacking Able to swallow Tablets
Item
1. are unable to swallow tablets.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Unable to discontinue Carbamazepine | Unable to discontinue Phenobarbital | Unable to discontinue Phenytoin
Item
2. unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
boolean
C1548265 (UMLS CUI [1,1])
C0006949 (UMLS CUI [1,2])
C1548265 (UMLS CUI [2,1])
C0031412 (UMLS CUI [2,2])
C1548265 (UMLS CUI [3,1])
C0031507 (UMLS CUI [3,2])
Epidermal growth factor receptor inhibitor | erlotinib
Item
3. have previously been treated with an epidermal growth factor receptor (egfr) inhibitor, including erlotinib.
boolean
C1443775 (UMLS CUI [1])
C1135135 (UMLS CUI [2])
Cancer treatment Other
Item
4. are receiving concurrent administration of any other antitumor therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Drugs, Non-Prescription
Item
5. have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1])
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